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CTRI Number  CTRI/2020/10/028319 [Registered on: 09/10/2020] Trial Registered Prospectively
Last Modified On: 05/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the efficacy and safety of fixed dose combination of Teneligliptin and Pioglitazone in the treatment of type 2 diabetes mellitus. 
Scientific Title of Study   A Phase III, Prospective, Randomized, Double Blind, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Teneligliptin 20 mg plus Pioglitazone 15 mg Tablets and FDC of Teneligliptin 20 mg plus Pioglitazone 30 mg Tablets Versus Teneligliptin Tablets 20 mg and Pioglitazone Tablets 30 mg in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRPL/CT/19/007  Protocol Number 
Version No.03, Dated Jun 24, 2020  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Gopal Rao 
Designation  Associate Professor 
Affiliation  Government Medical College & Government General Hospital (Old RIMSGGH) 
Address  Department of General Medicine, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam-532001.

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  8942279033  
Fax    
Email  drgopalraoa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rahul Vij 
Designation  AGM - Regulatory Affairs 
Affiliation  Synokem Pharmaceuticals Ltd. 
Address  Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi

New Delhi
DELHI
110087
India 
Phone  9999225948  
Fax    
Email  dra.domestic@synokempharma.com  
 
Details of Contact Person
Public Query  
Name  Rahul Vij 
Designation  AGM - Regulatory Affairs 
Affiliation  Synokem Pharmaceuticals Ltd. 
Address  Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi

New Delhi
DELHI
110087
India 
Phone  9999225948  
Fax    
Email  dra.domestic@synokempharma.com  
 
Source of Monetary or Material Support  
Synokem Pharmaceuticals Ltd. Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. 
 
Primary Sponsor  
Name  Synokem Pharmaceuticals Ltd 
Address  Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Poorna Gopal Azad  Anu Hospitals  Department of Clinical Research, Kovelamudivaristreet, Suryaraopet, Vijayawada-520002.
Krishna
ANDHRA PRADESH 		 7794022370

drcresearch@gmail.com 
Dr Vipul Khandelwal  Apex Hospitals Private Limited  Department of Clinical Research, SP-4 & 6, Malviya Industrial Area, Near Apex Circle, Malviya Nagar, Jaipur-302017.
Jaipur
RAJASTHAN 		 9829193517

dr.vipul@yahoo.co.in 
Dr Arindam Naskar  Calcutta School of Tropical Medicine  Department of Clinical Research, Calcutta School of Tropical Medicine, Govt. of West Bengal, 108, Chittranjan Avenue, Calcutta-700073.
Kolkata
WEST BENGAL 		 9874749626

dr.arindam83@gmail.com 
Dr Pardeep Agarwal  Chirayu Hospital  Department of Clinical Research, Hathoj, Kalwar Road, Jaipur-302012.
Jaipur
RAJASTHAN 		 9772846140

pradeepagarwal@yahoo.com 
Dr Hrishikesh Bora  Down Town Hospital  Down Town Hospital, Dispur, G.S. Road, Guwahati-781006, Assam.
Kamrup
ASSAM 		 9864044323

hris_11@yahoo.co.in 
Dr D Anil Kumar  Gandhi Medical College / Hospital  Department of General Medicine, Gandhi Medical College / Hospital, Musheerabad, Secunderabad-500003, Telangana.
Hyderabad
TELANGANA 		 9440523902

anilddrmd@gmail.com 
Dr A Gopal Rao  Government Medical College & Government General Hospital (Old RIMSGGH)  Department of General Medicine, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh.
Srikakulam
ANDHRA PRADESH 		 8942279033

drgopalraoa@gmail.com 
Dr Richa Giri  GSVM Medical College  Post Graduate Department of Medicine, GSVM Medical College, Kanpur-208002, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH 		 8400331045

krricha227@gmail.com 
Dr Sanjiv Maheshwari  Jawahar Lal Nehru (J.L.N) Medical College  Department of Medicine, Jawahar Lal Nehru (J.L.N) Medical College, Kala Bagh, Ajmer-305001, Rajasthan.
Ajmer
RAJASTHAN 		 9460479888

doctor.sanjiv@gmail.com 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Superspeciality Hospital  Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039, Rajasthan.
Jaipur
RAJASTHAN 		 9983995050

agrasenhospital2003@gmail.com 
Dr Raja Bhattacharya  Medical College and Hospital  Medical College and Hospital, Kolkata, MCH Building, 4th Floor, 88 College Street, Kolkata-700073, West Bengal.
Kolkata
WEST BENGAL 		 9477305539

rbrbhattacharya@gmail.com 
Dr Vikas Reddy Maddali  Osmania Medical College & General Hospital  Osmania Medical College & General Hospital, Afzalgunj, Hyderabad, Telangana-500012.
Hyderabad
TELANGANA 		 9491928493

vikasreddy04@gmail.com 
Dr Vijaykumar Shivajirao Patil  Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R)  Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R), Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali, Maharashtra-415409.
Sangli
MAHARASHTRA 		 9371877555

prakashmc.research@gmail.com 
Dr Vijaykumar Bhagwan Barge  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002, Maharashtra.
Kolhapur
MAHARASHTRA 		 8080328480

rscmgmc.research@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital and Research Centre  Department of Clinical Research, Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oshalbag, Dhargal, Tal-Pernem-403513.
North Goa
GOA 		 7498002214

redkar.research@gmail.com 
Dr Mohan Kumar Singh  W Pratiksha Hospital  Department of Clinical Research, Basement-2, W Pratiksha Hospital, Golf Course Ext. Road, Sushant Lok II, Sector 56, Gurugram-122011.
Gurgaon
HARYANA 		 9910431665

drmksingh2012@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, School of Tropical Medicine  Approved 
Ethics Committee, Down Town Hospital  Approved 
Ethics Committee, GSVM Medical College  Approved 
Institutional Ethics Committee for Human Research Medical College  Approved 
Institutional Ethics Committee, Anu Hospitals  Approved 
Institutional Ethics Committee, Apex Hospitals Private Limited  Approved 
Institutional Ethics Committee, Chirayu Hospital  Approved 
Institutional Ethics Committee, Gandhi Medical College and Hospital  Approved 
Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH)  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital  Approved 
Institutional Ethics Committee, Osmania Medical College  Approved 
Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)  Approved 
North East Healthcare Private Limited  Approved 
Prakash Medical College Institutional Ethics Committee  Approved 
Redkar Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC of Teneligliptin 20 mg plus Pioglitazone 15 mg Tablets  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 24 weeks 
Intervention  FDC of Teneligliptin 20 mg plus Pioglitazone 30 mg Tablets  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 24 weeks 
Comparator Agent  Pioglitazone Tablets 30 mg  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 24 weeks 
Comparator Agent  Teneligliptin Tablets 20 mg  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 24 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus.
2. Patients who have received stable dose of Metformin ≥ 1000 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 7% to ≤ 10%.
3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
4. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with the protocol requirements. 
 
ExclusionCriteria 
Details  1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
3. Patients with Fasting Plasma Glucose (FPG) > 220 mg/dL at screening (If FPG is > 220 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 220 mg/dL, patient will be excluded from the study).
4. Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening.
5. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
6. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
7. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
8. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
9. Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
10. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study. For male patients with mean QTcB ≥ 450 msec or female patients with mean QTcB ≥ 470 msec, triplicate ECG will be performed. If mean QTcB is ≥ 450 msec in males or mean QTcB is ≥ 470 msec in females on triplicate ECG, patient will be excluded from the study.
11. Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
12. Patients who are accepting treatments of arrhythmias.
13. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
14. Patients with known history of acute pancreatitis.
15. Patients with a history of treatment with estrogens and other medications known to affect bone.
16. Patients with history of clinically significant peripheral edema in past 6 months.
17. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other DPP4 inhibitors or thiazolidinediones.
18. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
19. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
20. Patients with history of any malignancy.
21. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
22. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
23. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
24. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
25. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
26. Suspected inability or unwillingness to comply with the study procedures.
27. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (24 weeks).  Baseline, Week 12 and Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (24 weeks).  Baseline, Week 2, Week 6, Week 12, Week 18 and Week 24 
Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (24 weeks).  Baseline, Week 2, Week 6, Week 12, Week 18 and Week 24 
Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (24 weeks).  Week 24 
 
Target Sample Size   Total Sample Size="328"
Sample Size from India="328" 
Final Enrollment numbers achieved (Total)= "344"
Final Enrollment numbers achieved (India)="344" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/10/2020 
Date of Study Completion (India) 10/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This trial is a phase III, prospective, randomized, double blind, comparative, parallel group, multicenter clinical study to evaluate the efficacy, safety and tolerability of FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets and FDC of Teneligliptin 20 mg + Pioglitazone 30 mg Tablets versus Teneligliptin Tablets 20 mg and Pioglitazone Tablets 30 mg in patients with type 2 diabetes mellitus inadequately controlled on Metformin monotherapy.

 

Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 to 65 years (both inclusive), who are on the treatment with Metformin Tablets ≥1000 mg/day for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of ≥ 7% to ≤ 10%] will be considered for the study.

 

Patients will be assigned to either of the four arms i.e. Arm A or Arm B or Arm C or Arm D consisting of FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets or FDC of Teneligliptin 20 mg + Pioglitazone 30 mg Tablets or Teneligliptin Tablets 20 mg or Pioglitazone Tablets 30 mg. Patients will be given the study medication once daily for 24 weeks. In addition, subjects will continue to receive Metformin at stable doses of ≥1000 mg/day, throughout the study period in an open label manner (24 weeks).

 

After confirming the inclusion/exclusion criteria the subject will be randomized and provided with study medication at randomization visit. Subjects will be provided with diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 2/day 14(±2), week 6/day 42(±2), week 12/day 84(±2), week 18/day 126(±2) and week 24/day 168(±2) (Final Visit) of treatment to assess efficacy, safety and tolerability.

 
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